Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01120028 | Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy | PHASE2 | COMPLETED | 852 | — | — | Sep 1, 2010 | Mar 1, 2020 | Apr 2, 2020 | 20 | United Kingdom |
Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))
Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.
| Arm | Type | Description |
|---|---|---|
| Alemtuzumab/Sirolimus | EXPERIMENTAL | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
| Alemtuzumab/Tacrolimus | EXPERIMENTAL | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
| Basiliximab/Tacrolimus | ACTIVE_COMPARATOR | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
| Basiliximab/Sirolimus | ACTIVE_COMPARATOR | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
| Name | Type | Description |
|---|---|---|
| Alemtuzumab | DRUG | Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart |
| Basiliximab | DRUG | 20 mg intravenously, two doses 96 hours apart |
| Sirolimus | DRUG | Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL |
| Tacrolimus | DRUG | Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization. |
Inclusion Criteria: * men or women aged over 18 years * recipient of kidney transplant (planned in next 24 hours) Exclusion Criteria: * recipients of multi-organ transplant * previous treatment with Campath-1H * active infection (including HIV, hepatitis B or C) * history of anaphylaxis to humani...